Singapore legislation
Regulation 43
Regulation 43
Information on validity of data submitted to or considered by Authority
Subregulation 1
A registrant of a therapeutic product must, within 15 days after receiving any information that adversely affects the validity of any data furnished by the registrant to the Authority relating to the quality, safety or efficacy of any therapeutic product to which the registrant’s registration relates, inform the Authority of such information.
Subregulation 2
A registrant of a therapeutic product who fails to comply with paragraph (1) shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $10,000 or to imprisonment for a term not exceeding 6 months or to both.
Subregulation 3
A registrant of a therapeutic product who, in compliance or purported compliance with paragraph (1), furnishes the Authority with any information which the registrant knows is false or misleading, shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $20,000 or to imprisonment for a term not exceeding 12 months or to both.